Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial
Official title:
A CCLG/Cancer Research UK Phase I Trial of AT9283 (a Selective Inhibitor of Aurora Kinases) Given for 72 Hours Every 21 Days Via Intravenous Infusion in Children and Adolescents With Relapsed and Refractory Solid Tumors
Verified date | November 2019 |
Source | Cancer Research UK |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: AT9283 may stop the growth of tumor cells by blocking some of the enzymes needed
for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of AT9283 in children
and adolescents with relapsed and refractory solid tumors.
Status | Completed |
Enrollment | 33 |
Est. completion date | November 20, 2019 |
Est. primary completion date | January 25, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 18 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed solid tumor meeting 1 of the following criteria: - Refractory to conventional treatment - Disease for which no conventional therapy exists - Patients with CNS tumors must be on a stable or decreasing dose of dexamethasone for = 1 week before study entry PATIENT CHARACTERISTICS: - WHO performance status (PS) 0-2 OR Lansky Play PS 70-100% (> 50% is acceptable if it is due to a stable neurological deficit or CNS tumor) - Life expectancy = 12 weeks - ANC = 1,000/mm^3 - Platelet count = 100,000/mm^3 - Hemoglobin = 9.0 g/dL - Serum bilirubin < 1.5 times upper limit of normal (ULN) - Creatinine kinase normal - ALT or AST < 2.5 times ULN (= 5 times ULN if due to tumor) - Creatinine clearance/EDTA-measured GFR = 60 mL/min - Sufficient blood volume to undergo the blood-sampling regimen specified by the protocol that, in the opinion of the investigator, will not jeopardize patient's safety - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use 2 methods of effective contraception 4 weeks before, during, and for 6 months after completion of study therapy - Not at high medical risk because of non-malignant systemic disease, including active uncontrolled infection - Not known to be serologically positive for hepatitis B or C or HIV - Fractional shortening of > 29% on echocardiogram - LVEF = 50% - No history of allergy or auto-immune disease - No congenital heart disease - No other condition that, in the investigator's opinion, would not make the patient a good candidate for the clinical trial PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Recovered from prior therapy - More than 4 weeks since prior radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy, or chemotherapy (6 weeks for investigational medicinal products, 2 weeks for vincristine) - More than 3 months since prior autologous stem cell transplantation - No prior allogenic bone marrow transplantation - No prior extensive radiotherapy to > 25% of bone marrow - No prior Aurora kinase inhibitor - No prior major thoracic or abdominal surgery from which the patient has not yet recovered - No prior or concurrent participation in another interventional clinical trial - Participation in an observational study allowed - No other concurrent anticancer therapy or investigational drugs |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Birmingham Children's Hospital | Birmingham | England |
United Kingdom | Leeds General Infirmary | Leeds | England |
United Kingdom | Royal Manchester Children's Hospital | Manchester | England |
United Kingdom | Great North Children's Hospital, Royal Victoria Infirmary | Newcastle-Upon-Tyne | England |
United Kingdom | Royal Marsden - Surrey | Sutton | England |
Lead Sponsor | Collaborator |
---|---|
Cancer Research UK |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose-limiting toxicities | |||
Primary | Maximum-tolerated dose | |||
Secondary | Pharmacokinetic parameters and the correlation between them and toxicity and/or efficacy | |||
Secondary | The magnitude and duration of biomarkers (M30 and M65 ELISA) change after AT9283 administration | |||
Secondary | Objective tumor response according to RECIST criteria |
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